Beschreibung
The purpose of the role is to focus on life cycle management activities for projects within medical devices .Tasks :
Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement. * Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies. * Conduct and lead design verification and validation activities. * Conduct and lead design / process failure mode effects and analysis. * Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc. * Provide leadership in the understanding of medical device regulations to other disciplines. * Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing. * Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times. * Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations. * Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
PROFESSIONAL EXPERIENCE REQUIREMENTS
* A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field is required. * Proven exceptional written and oral presentation skills * Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required. * Previous Quality Engineering experience is preferred. * Experience in an Medical Device regulated environment * Strong knowledge and skills in MS Office * Excellent problem solving, decision-making, and root cause analysis skills are required. * Interpersonal skills that foster conflict resolution are required. * Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred. * Ability to multi-task independently with minimal supervision * Fluency in English is required, good knowledge of German would be a strong asset.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.